BackgroundSelective cyclooxygenase-2 inhibitors and conventional non-selective non-steroidal anti-inflammatory drugs (nsNSAIDs) have been associated with adverse cardiovascular (CV) effects. We compared the CV safety of switching to celecoxib vs. continuing nsNSAID therapy in a European setting.MethodPatients aged 60 years and over with osteoarthritis or rheumatoid arthritis, free from established CV disease and taking chronic prescribed nsNSAIDs, were randomized to switch to celecoxib or to continue their previous nsNSAID. The primary endpoint was hospitalization for non-fatal myocardial infarction or other biomarker positive acute coronary syndrome, non-fatal stroke or CV death analysed using a Cox model with a pre-specified non-inferiority limit of 1.4 for the hazard ratio (HR).ResultsIn total, 7297 participants were randomized. During a median 3-year follow-up, fewer subjects than expected developed an on-treatment (OT) primary CV event and the rate was similar for celecoxib, 0.95 per 100 patient-years, and nsNSAIDs, 0.86 per 100 patient-years (HR = 1.12, 95% confidence interval, 0.81–1.55; P = 0.50). Comparable intention-to-treat (ITT) rates were 1.14 per 100 patient-years with celecoxib and 1.10 per 100 patient-years with nsNSAIDs (HR = 1.04; 95% confidence interval, 0.81–1.33; P = 0.75). Pre-specified non-inferiority was achieved in the ITT analysis. The upper bound of the 95% confidence limit for the absolute increase in OT risk associated with celecoxib treatment was two primary events per 1000 patient-years exposure. There were only 15 adjudicated secondary upper gastrointestinal complication endpoints (0.078/100 patient-years on celecoxib vs. 0.053 on nsNSAIDs OT, 0.078 vs. 0.053 ITT). More gastrointestinal serious adverse reactions and haematological adverse reactions were reported on nsNSAIDs than celecoxib, but more patients withdrew from celecoxib than nsNSAIDs (50.9% patients vs. 30.2%; P < 0.0001).InterpretationIn subjects 60 years and over, free from CV disease and taking prescribed chronic nsNSAIDs, CV events were infrequent and similar on celecoxib and nsNSAIDs. There was no advantage of a strategy of switching prescribed nsNSAIDs to prescribed celecoxib. This study excluded an increased risk of the primary endpoint of more than two events per 1000 patient-years associated with switching to prescribed celecoxib.Clinical Trial Registration https://clinicaltrials.gov/show/NCT00447759; Unique identifier: NCT00447759.

Background: The high rates of complications and reoperations observed with the early designs of firstgeneration (unlocked) and second-generation (bent design) humeral intramedullary nail (IMNs) have discouraged their use by most surgeons. The purpose of this study was to report the results of a thirdgeneration (straight, locking, low-profile, tuberosity-based fixation) IMN, inserted through a percutaneous approach, for the treatment of displaced 2-part surgical neck fractures. Methods: We performed a retrospective review of 41 patients who underwent placement of a thirdgeneration IMN to treat a displaced 2-part surgical neck fracture (AO/OTA type 11A3). The mean age at surgery was 57 years (range, 17-84 years). After percutaneous insertion through the humeral head, the IMN was used as a reduction tool. Static locking fixation was achieved after axial fracture compression ("back-slap" hammering technique). Patients were reviewed and underwent radiography with a minimum of 1 year of follow-up; the mean follow-up period was 26 months (range, 12-53 months). Results: Preoperatively, 3 types of surgical neck fractures were observed: with valgus head deformity (Type A = 8 cases), shaft translation without head deformity (Type B = 19 cases), or with varus head deformity (Type C = 14 cases). At final follow-up, all fractures went on to union, and the mean humeral neck-shaft angle was 132°± 5°. We observed 2 malunions and 1 case of partial humeral head avascular necrosis. No cases underwent screw migration or intra-articular penetration. At last review, mean active forward elevation was 146°(range, 90°-180°) and mean external rotation was 50°(range, 20°-80°). The mean Constant-Murley score and Subjective Shoulder Value were 71 (range, 43-95) and 80% (range, 50%-100%), respectively. Conclusions: Antegrade insertion of a third-generation IMN through a percutaneous approach provides a high rate of fracture healing, excellent clinical outcome scores, and a low rate of complications. No morbidity related to the passage of the nail through the supraspinatus muscle and the cartilage was observed. The proposed A, B, and C classification allows choosing the optimal entry point for intramedullary nailing. The study was approved by the Institutional Review Board of Institut Universitaire Locomoteur et du Sport (No. 2016-02).

A 3 × 4 electrode array was placed over each of seven muscles and surface electromyography (sEMG) data were collected during isometric contractions. For each array, nine bipolar electrode pairs were formed off-line and sEMG parameters were calculated and evaluated based on repeatability across trials and comparison to an anatomically placed electrode pair. The use of time-domain parameters for the selection of an electrode pair from within a grid-like array may improve upon existing electrode placement methodologies.

A variety of factors affect the performance of a person using a myoelectric prosthesis, including increased control noise, reduced sensory feedback, and muscle fatigue. Many studies use able-bodied subjects to control a myoelectric prosthesis using a bypass socket in order to make comparisons to movements made with intact limbs. Depending on the goals of the study, this approach can also allow for greater subject numbers and more statistical power in the analysis of the results. As we develop assessment tools and techniques to evaluate how peripheral nerve interfaces impact prosthesis incorporation, involving normally limbed subjects in the studies becomes challenging. We have designed a novel bypass prosthesis to allow for the assessment of prosthesis incorporation in able-bodied subjects. Incorporation of a prosthetic hand worn by a normally limbed subject requires that the prosthesis is a convincing, functional extension of their own body. We present the design and development of the bypass prosthesis with special attention to mounting position and angle of the prosthetic hand, the quality of the control system and the responsiveness of the feedback. The bypass prosthesis has been fitted with a myoelectrically-controlled hand that has been instrumented to measure the forces applied to the thumb, index, and middle fingers. The prosthetic hand was mounted on the bypass socket such that it is the same length as the subject's intact limb but at a medial rotation angle of 20° to prevent visual occlusion of the prosthetic hand. Force feedback is provided in the form of electrical stimulation, vibration, or force applied to the intact limb with milliseconds of delay. Preliminary data results from a cross-modal congruency task are included showing evidence of prosthesis incorporation in able-bodied subjects. This bypass will allow able-bodied subjects to participate in research studies that require the use of a prosthetic limb while also allowing the subjects to sense that the prosthesis is an extension of the body.

AIMSTo measure the impact of newspaper advertising across Scotland on patient interest, and subsequent recruitment into the Standard Care vs. Celecoxib Outcome Trial (SCOT), a clinical trial investigating the cardiovascular safety of non-steroidal anti-inflammatory drugs in patients with osteoarthritis or rheumatoid arthritis. METHODSNewspaper advertisements about the SCOT trial were placed sequentially in regional and national Scottish newspapers. The number of phone calls as a result of exposure to the advertisements and ongoing study recruitment rates were recorded before, during and after the advertising campaign. To enroll in SCOT individuals had to be registered with a participating GP practice. RESULTSThe total cost for the advertising campaign was £46 250 and 320 phone calls were received as a result of individuals responding to the newspaper advertisements. One hundred and seventy-two individuals were identified as possibly suitable to be included in the study. However only 36 were registered at participating GP practices, 17 completed a screening visit and 15 finally were randomized into the study. The average cost per respondent individual was £144 and the average cost per randomized patient was £3083. Analysis of recruitment rate trends showed that there was no impact of the newspaper advertising campaign on increasing recruitment into SCOT. CONCLUSIONSAdvertisements placed in local and national newspapers were not an effective recruitment strategy for the SCOT trial. The advertisements attracted relatively small numbers of respondents, many of whom did not meet study inclusion criteria or were not registered at a participating GP practice.

Purpose: To report the outcomes of all-arthroscopic coracoclavicular (CC) ligament reconstruction and simultaneous diagnosis and treatment of glenohumeral pathologies in patients with symptomatic, chronic (>6 weeks), complete (Rockwood type III-V) acromioclavicular joint (ACJ) separations. Methods: We prospectively followed up 57 consecutive patients treated arthroscopically for chronic Rockwood type III (n ¼ 11), type IV (n ¼ 19), and type V (n ¼ 27) ACJ dislocations. Previous ACJ surgery failed in 11 (19%). The mean delay between injury and surgery was 39 months (range, 6 months to 17 years). The mean age at surgery was 42 years (range, 19-71 years). After glenohumeral exploration, an arthroscopic modified Weaver-Dunn procedure with CC suture button fixation (Twinbridge) was performed. The CC reduction and tunnel position were analyzed with radiographs and computed tomography. The mean follow-up period was 36 months (range, 12-72 months). Results: Intra-articular pathology was treated arthroscopically in 27 patients (48%): 17 labral tears, 8 rotator cuff tears (3 partial and 5 complete), and 15 biceps lesions (4 SLAP lesions and 11 subluxations). At last follow-up, 7 patients (12%) experienced recurrent ACJ instability: 2 frank dislocations (1 trauma and 1 infection) and 5 ACJ subluxations. There was no significant correlation between subluxation and clinical outcome. The rate of recurrent ACJ instability was significantly higher in patients with higher-grade ACJ dislocations (P < .01) and/ or previous failed surgery (P < .001). Recurrent subluxation was observed in 3 cases of lateral migration of the coracoid button with lateral tunnel placement, as well as 2 cases of anterior migration of the clavicular button with anterior tunnel placement. The Constant score increased from 67 (range, 28-89) to 85.5 (range, 66-100), and the mean Subjective Shoulder Value increased from 54% to 85% (P < .001). At last follow-up, 95% of patients (54 of 57) were satisfied. Conclusions: All-arthroscopic treatment allows successful CC ligament reconstruction and simultaneous diagnosis and treatment of frequently associated (48%) glenohumeral lesions. Higher-grade ACJ dislocations, previous ACJ surgery, and misplacement of bone tunnels are risk factors for recurrent instability. Level of Evidence: Level IV, case series.

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